Augmented Macular Pigment-containing Nutraceutical and Central Visual Function

September 30, 2022 updated by: University of the Incarnate Word

Augmented Macular Pigment Supplement and Pericentral Visual Function: a Randomized Controlled Trial

The purpose of this study is to prospectively analyze changes in macular pigment optical density and dermal carotenoid levels as they relate to visual field function in patients prescribed a macular pigment-containing medical food (Lumega-Z), in combination with a topical carbonic anhydrase inhibitor.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This is a prospective double-masked, randomized controlled trial which evaluates central visual field function as it relates to macular pigment optical density, contrast sensitivity, and dermal carotenoid levels in the presence of a commercial macular pigment-containing medical food (Lumega-Z). Participants will be randomized to twelve weeks of supplement + dorzolamide or twelve weeks of placebo. All packaging of supplement and dorzolamide and the placebo will be identical and distributed by a third party. Both subjects and the investigators examining patients will be masked to placebo and experimental group assignment.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78215
        • Ophtalmology Clinic of William E Sponsel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Glaucoma diagnosis (H40. *) with abnormal visual field as measured by 30-2 Humphrey Perimetry (mean deviation < -2.00)
  • Adequate IOP control (IOP > 7 mmHg and < 22 mmHg) by medical or surgical means measured by Goldman Applanation Tonometry for at least 3 months
  • Visual field progression - decrease (more negative) in MD by 1.00 dB or more when compared to prior HVF)
  • Refractive error ≤ 10 diopters and astigmatism ≤ 3 diopters

Exclusion Criteria:

  • BCVA worse than 20/200
  • Pt Is unable to tolerate MPOD, CS, dermal carotenoid measurement-taking procedures
  • Loss of IOP control requires surgical intervention
  • Patient already taking AREDS formula oral supplement
  • Patient taking medication or dietary supplements that may interact with LM ingredients
  • History of photosensitive epilepsy
  • History of penetrating ocular trauma or vitrectomy
  • History of ocular or orbital radiation therapy or is currently receiving chemotherapy
  • Women who are nursing, pregnant, or are planning pregnancy
  • Has a known adverse reaction (including sulfa allergy) and/or sensitivity to the study supplement or its ingredients including: N-acetyl-cysteine, acetyl-L-carnitine, L-taurine, quercetin, Co-enzyme Q-10, lutein, meso zeaxanthin, zeaxanthin, astazanthin, lycopene, alpha-lipoic acid.
  • Currently enrolled in an investigational drug study or has used an investigational drug within 30 days prior to recruitment.
  • Is planning on having ocular surgery at any time throughout the study duration, or had ocular surgery < 3 months before enrollment
  • Native lens opacity ≥ grade 3 on ARLNS standard photograph
  • Blue light filter intraocular lens

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Subjects in the experimental arm will consume 1.5 Tbsp (22.2 mL) of a commercial macular pigment-containing medical food (liquid) once per day and use a carbonic anhydrase inhibitor topical eye drop (2% dorzolamide ophthalmic solution) three times per day in both eyes for 3 months.
Dietary supplement: Lumega-Z
Medical food which contains lutein, zeaxanthin, and meso-zeaxanthin
Drug: Dorzolamide Hcl 2% Oph Soln
Topical carbonic anhydrase inhibitor
Other Names:
  • Azopt
Placebo Comparator: Placebo
Subjects in the placebo arm will consume 1.5 Tbsp (22.2 mL) of a placebo liquid which resembles the commercial macular pigment-containing medical food (liquid) in taste once per day and use a lubricating eye drop (0.5% sodium + 0.9% glycerin ophthalmic solution) three times per day in both eyes for 3 months.
Other: Placebo
Specially formulated non macular pigment-containing formulation which tastes similar to the commercial medical food being evaluated in this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pericentral Visual Function
Time Frame: 3 Months
Mean deviation and pattern standard deviation of 10-2 Humphrey visual field
3 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Macular Pigment Optical Density
Time Frame: Monthly for 3 months
Macular Pigment Optical Density measured by Mapcat SF
Monthly for 3 months
Dermal Carotenoid Levels
Time Frame: Monthly for 3 months
Measured by Veggie Meter
Monthly for 3 months
Contrast Sensitivity
Time Frame: Monthly for 3 months
Measured by Vector Vision CSV-2000
Monthly for 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the Incarnate Word

Collaborators

Guardion Health Sciences, Inc.

Investigators

  • Principal Investigator: Grant T Slagle, DO, Sponsel Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2021

Primary Completion (Anticipated)

May 1, 2022

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

December 9, 2020

First Submitted That Met QC Criteria

December 17, 2020

First Posted (Actual)

December 19, 2020

Study Record Updates

Last Update Posted (Actual)

October 4, 2022

Last Update Submitted That Met QC Criteria

September 30, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-11-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is no plan to share IPD to other researches.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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